§ Mr. BurnsTo ask the Secretary of State for Health if he will make a statement on the link between women taking the contraceptive pill or on hormone replacement therapy and their likelihood of suffering a deep vein thrombosis; and what measures are being taken to advise and make aware these vulnerable groups of the dangers of DVT and how to lower the risk of suffering from it. [46830]
§ Yvette Cooper[holding answer 10 April 2002]: A very small increase in the risk of developing deep vein thrombosis (DVT) for women who take oral contraceptives (OCs) or hormone replacement therapy (HRT) has been recognised for many years. Accordingly, OCs and HRT are contraindicated in women who have a personal or family history of DVT and who are therefore most at risk.
In 1995 several new studies suggested that a slightly increased risk of DVT was associated with newer OCs (the so-called third generation pills that contain desogestrel or gestodene as progestogen) compared to older ones (so-called second generation pills that contain levonorgestrel as progestogen). This issue was considered by the Committee on Safety of Medicines (CSM) in 1995, 1996 and 2001 and by the Medicines Commission in 1998 as more data became available. They have advised that 788W for every 100,000 women who use OCs for a year, 10–20 more cases of DVT may be expected to occur relative to healthy non-users. This increase in risk is less than the risk of DVT associated with pregnancy (an extra 55 cases of DVT for every 100,000 pregnancies).
Warnings about the risk of DVT in women who take OCs have been in the Summary of Product Characteristics (SPCs) for health professionals and the patient information leaflet (PIL) for women for many years. These warnings were updated with respect to the increased risk of DVT in women who use third, as opposed to second, generation pills in early 1999 and were included in the BNF (British National Formulary). In 2001, product information for all combined oral contraceptives was further updated to inform women and their health professionals that their risk of DVT is greatest in the first year they ever use an OC. Comprehensive information about the risk of DVT with use of oral contraceptives was provided to health professionals and women in a Dear Doctor letter in 1995, in an article in the Medicine Control Agency's (MCA) safety bulletin "Current Problems in Pharmacovigilance" in 1999 and on the MCA's website in 2001.
With respect to HRT, evidence suggesting an increased risk for DVT was considered by CSM in 1996. They advised that an additional 10–20 women may experience a DVT out of every 100,000 women who use HRT compared with healthy non-HRT users of a similar age. The SPCs and PILs for HRT products and the BNF were updated in line with this advice in 1998. Health professionals were informed of the risk of DVT in association with use of HRT in an article in "Current Problems in Pharmacovigilance" which contained a pull-out sheet with information specifically for women.
In addition to targeted information, every pack of oral contraceptives and HRT contains a PIL for women. These clearly inform women that they should not use OCs or HRT if they have a personal or family history of DVT. They also inform women of their additional risk of DVT compared with non-users. PILs for the second and third generation OCs describe what DVT is and how it is caused, its potential severity and possible outcome. They also list the symptoms of DVT and advise women to stop taking their pills immediately and seek medical help in the event of their occurrence. In addition, they advise women to stop taking their pills prior to periods of prolonged immobilisation, especially surgery and to re-start only when fully re-mobilised. Any woman wishing to take OCs is encouraged to discuss the risks of DVT with her doctor and, provided she understands and accepts those risks, to jointly choose the treatment that is best suited to her in light of her individual medical history.
§ Mr. BurnsTo ask the Secretary of State for Health how many people in England have been diagnosed with deep vein thrombosis in(a) each of the last six years and (b) 2002 to the latest available date. [46743]
§ Yvette Cooper[holding answer 10 April 2002]: The information shown in the table is the number of admissions to national health service hospitals in England where the patient's main diagnosis was Deep Vein Thrombosis.
789W
Year Finished consultant episode 1995–96 19,598 1996–97 20,736 1997–98 22,551 1998–99 24,871 1999/2000 25155 2000/01 24,903 Notes:
Admissions are defined as the first period of patient care under one consultant within one health care provider. Admissions do not represent the number of patients, as a person may have more than one admission within the year.
Figures are only given for NHS hospital in-patient admissions; there are no figures available for patients diagnosed or treated elsewhere. The figures are the latest available.
The figures for 1995–96 to 1999–2000 are grossed for both coverage and invalid/unknown clinical data, but the figure for 2000–01 have not yet been adjusted for shortfalls in data (i.e. it is ungrossed).
Source:
Hospital Episode Statistics (HES), Department of Health.
The International Classification of Diseases (ICD-10) code used: 180.2.